HomeSleepTest (HST, HST REM+)
K-Number: K240700 · 2024-12-08
ApplicantSomnomedics GmbH
Decision Date2024-12-08
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
HomeSleepTest (HST, HST REM+) is a medical device manufactured by Somnomedics GmbH. It received FDA 510(k) clearance on 2024-12-08 under approval number K240700. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HomeSleepTest (HST, HST REM+)?
HomeSleepTest (HST, HST REM+) is a medical device that received FDA 510(k) clearance on 2024-12-08. It is manufactured by Somnomedics GmbH. The 510(k) number is K240700.
When was HomeSleepTest (HST, HST REM+) approved by the FDA?
HomeSleepTest (HST, HST REM+) received FDA 510(k) clearance on 2024-12-08, under approval number K240700.
What company makes HomeSleepTest (HST, HST REM+)?
HomeSleepTest (HST, HST REM+) is manufactured by Somnomedics GmbH.
What is the FDA product code for HomeSleepTest (HST, HST REM+)?
The FDA product code for HomeSleepTest (HST, HST REM+) is OLV.
Other Devices by Somnomedics GmbH
Related Devices (Code: OLV)
K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO
K172711Comet-PLUSNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc.
K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc.
K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc.
K173690Grass TWinNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.